Symetis launches second product

Symetis SA, announced the launch of ACURATE neo, its transcatheter aortic valve implantation (TAVI) system. Commercial implantations started early September after Symetis received CE Mark approval for ACURATE neo this summer.

“With the transfemoral ACURATE neo the Symetis team successfully duplicated the intuitive use and solid performance that are the hallmarks of its transapical system ACURATE TA,” said principal investigator Prof. Helge Möllmann from the Department of Cardiology at the Kerckhof Klinik, Bad Nauheim, Germany.

“I found the ACURATE neo to be one of the easiest and most predictable transfemoral selfexpanding TAVI systems, and its clinical performance outstanding,” said Prof. Alexandre Abizaid, from the Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil, who conducted the Brazilian arm of the study.

“We are delighted with the performance and safety outcomes of our CE Mark study, along with its procedural success,” said Laura Brenton, VP Clinical & Regulatory of Symetis. “Reflecting an evolving European regulatory environment for medical devices, we brought over 90% of the patient cohort to the 12-month follow-up window. This is the most robust set of clinical data submitted for a TAVI CE Mark to date.”

The rollout of ACURATE neo will be modeled on the successful commercialization of Symetis’s transapical system, ACURATE TA, which has witnessed a remarkably rapid uptake in core European markets. “We look forward to working with heart teams across Europe that have gained experience with our transapical ACURATE TA to progressively establish ACURATE neo as a leading transfemoral TAVI solution,” said Jacques R. Essinger, CEO of Symetis. “With the launch of ACURATE neo, Edwards Lifesciences, Medtronic ,and Symetis are now the only companies offering dual access routes, transapical and transfemoral, for the delivery of transcatheter aortic heart valves.